Inclisiran
اینکلیسیران
❤️ Cardiovascular SystemPCSK9-directed siRNA
Market / country: 🇺🇸 USA
Leqvio (US)
🧮 Dose calculator
Hyperlipidemia / heterozygous familial hypercholesterolemia · Regimen source: FDA Leqvio · 2.1
🛡️ Safety & information
Contraindications
- ⛔ Prior serious hypersensitivity to inclisiran (anaphylaxis, angioedema). FDA Leqvio · 4
Formulations
- 284 mg/1.5 mL prefilled syringe — injection 🇺🇸 USA FDA Leqvio · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Leqvio · 8.1
“… us decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, LEQVIO may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Leqvio · 8.2
“Risk Summary There is no information on the presence of inclisiran in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Leqvio · 8.4
“The safety and effectiveness of LEQVIO as an adjunct to diet and other LDL-C-lowering therapies for the treatment of HeFH have been established in pediatric patients aged 12 years and older.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Leqvio · 8.5
“No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA214012
- DailyMed (FDA label)FDA Leqvio
- MedlinePlus (NIH)Inclisiran injection
- WHO ATC/DDDC10AX16
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Leqvio · 3FDA Leqvio · 2.1FDA Leqvio · 4FDA Leqvio · SPL approval / marketing categoryFDA Leqvio · 8.1FDA Leqvio · 8.2FDA Leqvio · 8.4FDA Leqvio · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified